Patent Foramen Ovale

Migraine is a common chronic neurological condition linked to patent foramen ovale PFO, a frequent congenital heart defect in adults. This research investigates the connection between PFO and migraines, focusing on the effects of closing the PFO to reduce migraine symptoms. Previous studies suggest that closing the PFO with metal devices can reduce migraine days but may also cause new or worsened migraines due to permanent metal implants. The study aims to compare outcomes using a new biodegradable PFO occluder versus a traditional metal occluder. Participants will be randomly assigned to receive either the innovative MemoSorb4 biodegradable occluder, which dissolves over time to avoid complications of metal implants, or the conventional metal occluder device. The biodegradable occluder acts as a temporary bridge that gradually degrades while the heart tissue repairs itself. This single-blind, controlled trial will evaluate the safety and effectiveness of these two devices in patients with both PFO and migraine. During the study, participants will be monitored for migraine frequency and severity, with the main outcome being the reduction in migraine days per month measured at 12 months after the procedure. Follow-ups will include clinical evaluations and diagnostic testing to assess device performance and migraine relief. The total study duration and safety monitoring will span at least one year post-implantation to compare long-term effects of the two occluder types.

The Abbott Structural Heart SH Registry is designed to confirm the safety and performance of Abbotts commercially available structural heart devices in real-world clinical settings. It collects data from routine hospital practices and standard-of-care procedures involving patients with various heart conditions such as atrial septal defect, ventricular septal defect, patent foramen ovale, and valvular heart disease. The study aims to meet regulatory requirements, including those from the European Union Medical Device Regulations 2017745, by conducting active post-market clinical follow-up for these devices. Participants in this observational registry receive structural heart devices like the Amplatzer Occlusion Devices for septal defects or the Epic Surgical Tissue Heart Valve devices for valve replacement as part of their standard care. Enrollment occurs either before the procedure or shortly afterward, depending on the device type. Follow-up visits align with routine care schedules and may be in-person, virtual, or by phone. Follow-up duration varies by device, ranging from discharge or 7 days post-procedure up to 10 years to monitor long-term performance and safety. A specific surgical valve sub-study is included to gather data for regulatory approval of certain valve sizes. Participants provide informed consent and are followed through standard care visits where data is collected about safety and effectiveness outcomes. The registry tracks primary safety endpoints at 7 days post-procedure and effectiveness at baseline. Follow-up assessments may include in-office or remote visits and data collection over months to years depending on the device implanted. The total participation duration depends on the device but can extend up to a decade, ensuring long-term monitoring of device performance in everyday clinical practice.

Researchers are collecting real-world data on patient outcomes to assess the success and performance of the Lifetech CeraFlex PFO Closure System, a device designed to close Patent Foramen Ovale PFO without surgery. This multicenter, prospective, observational study aims to provide valuable information on how well the device works in everyday medical practice. Participants will receive the CeraFlex PFO Closure System, which includes the CeraFlex PFO Occluder and the SteerEase Introducer. The study follows patients after the procedure, tracking their progress at discharge, and then at 1-3 months, 6 months, 12 months, and 24 months post-procedure. The enrollment period is expected to last about 18 months, with each participant followed for two years after device implantation. During the study, participants will undergo various assessments including monitoring for procedural success shortly after the procedure, checking for residual shunts at several follow-up points, and tracking stroke-related events, device deficiencies, serious adverse events, and deaths up to 24 months post-implantation. Data is collected electronically to ensure accurate tracking of patient outcomes over the entire study period.

This trial investigates the safety of stopping antithrombotic treatment 12 months after successful transcatheter closure of a patent foramen ovale PFO in young patients who have had a cryptogenic stroke or transient ischemic attack TIA. The study focuses on patients aged 18 to 60 years without other major risk factors, aiming to find out if shorter antiplatelet therapy after PFO closure reduces bleeding risks without increasing stroke or ischemic events. Participants will all have undergone successful PFO closure and will follow a plan to discontinue antiplatelet treatment 12 months after the procedure. Clinical evaluations and brain MRI scans are performed at 12 months before stopping treatment and again at 24 months post-PFO closure to monitor for new ischemic lesions or stroke events. During the study, participants will be closely monitored through clinical assessments and MRI imaging to detect any new strokes or ischemic brain lesions. Researchers will track the number and volume of new cerebral ischemic lesions and ischemic events over follow-ups extending up to 10 years, as well as bleeding rates. The total participation duration includes evaluations at 12 and 24 months, with continued monitoring of outcomes for several years.

Researchers are evaluating the Recross P3 Occluder System, a new heart device designed to close a small opening between the upper chambers of the heart called a Patent Foramen Ovale PFO. This trial focuses on adults aged 18 to 65 who have had a stroke that might be related to this heart opening. The main goal is to determine if the P3 Occluder System is safe and effective at closing the PFO to reduce the risk of another stroke. Participants will undergo a procedure to implant the P3 Occluder device if appropriate. After the procedure, they will have follow-up visits with their doctor at 1 month, 3 months, 6 months, 1 year, and 5 years to check their progress and device status. Additionally, study staff will contact participants by phone at 2, 3, and 4 years after the procedure to complete surveys. During the study, participants will be monitored for major heart-related events within 30 days and assessed for effective closure of the PFO at 6 months. Other safety evaluations include checking for serious device- or procedure-related events. The study also examines if the device remains correctly positioned at 6 months. Overall, participants will be involved in regular doctor visits, imaging tests, and surveys for up to 5 years to ensure thorough monitoring of their heart health and device performance.

Patent Foramen Ovale PFO is a common heart defect that may be linked to migraines, especially migraine with aura. Researchers are studying how PFO affects the brains glymphatic system and its connection to migraine symptoms. They aim to understand if closing the PFO can improve migraines and glymphatic function, using a case-control design to compare patients with and without migraine who have PFO with significant right-to-left shunt. The study involves two groups one with PFO and migraine who receive a minimally invasive percutaneous PFO closure procedure, and a control group with PFO but no migraine who do not receive closure. The closure uses a device inserted through a catheter to seal the PFO tunnel under imaging guidance. Both groups undergo assessments of migraine symptoms and glymphatic function before and six months after intervention or enrollment. Participants will be monitored for changes in migraine frequency and pain intensity, using tools like the Monthly Migraine Days and Visual Analogue Scale for pain. Glymphatic function is measured by imaging indexes such as the DTI-ALPS. The study takes place over at least six months post-procedure or enrollment, with the goal of understanding the effects and mechanisms of PFO closure on migraine and brain function.

Researchers are evaluating the safety, effectiveness, and noninferiority of the Encore PFO closure device compared to any FDA-approved PFO closure device chosen by investigators. The study focuses on patients who have had a cryptogenic stroke caused by a presumed paradoxical embolism and involves closing a patent foramen ovale PFO through a percutaneous, transcatheter procedure. This prospective, multicenter, randomized clinical study aims to provide reasonable assurance of the Encore devices safety and effectiveness. Participants will be randomly assigned to receive either the Encore PFO closure device, which includes an implant component and a single-use delivery system, or an FDA-approved PFO closure device selected by the investigator. The procedure involves using these devices to close the PFO via catheter-based delivery. The study design includes comparison of procedural and device-related outcomes between these two groups. During the study, participants will be monitored for safety, including the incidence of serious adverse events related to the device or procedure within 6 months. Effectiveness will be assessed by measuring the success of PFO closure at 6 months. Additional evaluations include long-term monitoring for recurrent stroke, transient ischemic attacks, new atrial arrhythmias, and procedural success over 5 years. Participants will undergo imaging, neurological assessments, and follow-up visits to track outcomes and overall safety throughout the study period.

Researchers are establishing a headache center in China to study migraine patients who also have patent foramen ovale PFO. The study aims to explore different treatment options for this combination, identify factors that may influence outcomes, and develop models to predict prognosis. The goal is to improve understanding and care for patients with both conditions. Participants will be assigned to one of three groups based on treatment approach a conservative group that does not use antiplatelet drugs or undergo PFO closure surgery, a group that receives antiplatelet drug treatment, and a group that undergoes PFO closure surgery. The study is observational and will follow patients over time to monitor their condition. During the study, participants will be regularly monitored for changes in migraine attacks at 3 months, 6 months, 1 year, 2 years, and 3 years. The study involves clinical, imaging, and laboratory examinations to gather detailed information. Participants will be followed up to assess the effects of their treatment approach and factors influencing migraine outcomes with PFO.

Researchers are evaluating a new heart device called the Recross P3 Occluder System in adults aged 18 to 65 who have a small opening between the upper chambers of the heart Patent Foramen Ovale or PFO and have experienced a stroke potentially linked to this heart opening. The study aims to determine if the P3 Occluder System is safe and effective for closing the PFO to reduce the risk of another stroke. Participants who qualify will undergo a procedure to implant the P3 Occluder System. The study includes follow-up visits with their doctor at 1 month, 3 months, 6 months, and 1 year after the procedure. Additionally, participants will receive phone calls from the study staff at 2 and 3 years after the procedure to complete surveys. During the study, participants will have exams to monitor the closure of the PFO and check for any cardiovascular events or complications. The main outcomes measured include effective closure of the PFO at 6 months and any adverse cardiovascular events within 30 days after the procedure. Researchers will also track device position and serious adverse events up to 6 months. The total participation may last up to 3 years with periodic assessments and surveys.

This research evaluates the safety and effectiveness of the GORE4 CARDIOFORM Septal Occluder device in adults who have had an ischemic stroke thought to be caused by a patent foramen ovale PFO, a heart condition. The study aims to assess device performance and the quality of operator training in real-world, post-approval settings. Up to 636 adults aged 18 to 70 will participate across up to 40 U.S. centers. Participants will receive the GORE4 CARDIOFORM Septal Occluder to close the PFO, combined with antiplatelet medical management. The device is commercially available and implanted as a one-time procedure. After implantation, participants will be followed for up to 5 years with scheduled visits at 1 month, 6 months, 12 months, and annually thereafter. Throughout the study, participants will undergo assessments including echocardiographic examinations to evaluate PFO closure and residual shunts, monitoring for new atrial arrhythmias, and tracking serious adverse events related to the device or procedure. The main outcomes include measuring the proportion of participants experiencing recurrent ischemic stroke up to 24 months after implantation and safety events within 30 days. This long-term follow-up allows careful evaluation of device performance and participant health over time.